Methods of closing wounds

ABSTRACT

In a preferred embodiment, a method for closing a subcutaneous arterial wound is provided which utilizes a patient&#39;s whole blood by homogenously exposing the patient&#39;s whole blood to a porous matrix to initiate the clotting cascade of the patient&#39;s whole blood and situating the patient&#39;s whole blood at a position proximate the arterial wound as the patient&#39;s whole blood is clotting. The method may include holding a subcutaneous mass comprising the patient&#39;s whole blood in position proximate the arterial wound as the patient&#39;s whole blood continues to clot, whereby a hemostatic closure comprising the patient&#39;s whole blood is formed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/146,139, filed Jan. 2, 2014 (now U.S. Pat. No. 9,669,131), which is acontinuation of U.S. patent application Ser. No. 13/852,094, filed Mar.28, 2013 (now U.S. Pat. No. 8,652,169), which is a continuation of U.S.patent application Ser. No. 13/724,520, filed Dec. 21, 2012 (now U.S.Pat. No. 8,568,448), which is a continuation of U.S. patent applicationSer. No. 11/337,278, filed Jan. 23, 2006 (now U.S. Pat. No. 8,652,168),which is a continuation of U.S. patent application Ser. No. 10/291,278,filed Nov. 8, 2002 (now U.S. Pat. No. 6,989,022), which is acontinuation of U.S. patent application Ser. No. 09/732,423, filed Dec.7, 2000 (now U.S. Pat. No. 6,478,808), which is a continuation of U.S.patent application Ser. No. 09/212,080, filed Dec. 15, 1998 (now U.S.Pat. No. 6,159,232), which claims benefit and priority of U.S.Provisional Patent Application No. 60/069,834, filed Dec. 16, 1997, allof which are incorporated by reference in their entirety.

FIELD OF THE INVENTION

This invention concerns novel methods and apparatuses for medicalapplications, specifically wound closure applications. Moreparticularly, the invention manipulates blood fluids, or its components,in new ways to close tissue or vascular wounds.

BACKGROUND

Numerous medical applications exist where sealing of biological tissueis desired. U.S. Pat. No. 5,510,102 to Cochrum identifies many of these,including for treating trauma of liver, spleen, pancreas, lung, bone,etc., for cardiovascular and vascular applications, such asmicrovascular anastomoses, vascular grafts, intraoperative bleeding, andaortic repair, for thoracic surgery, such as lung biopsy, for transplantof heart, renal, pancreas, lung, bone or bone marrow, for neurosurgery,such as nerve anastomoses or CSF leak repair, for endoscopic surgery,such as hemostasis in hepatic trauma or bile duct repair, forinterventional radiology, such as hemostasis for percutaneous liverbiopsy or vascular occlusion, for gastrointestinal surgery, such ascolonic anastomoses, for obstetrics and gynecology, such as rectovaginalfistulas, for pediatric and fetal surgery, for plastic surgery and burnrepairs, such as grafting process of cultured epidermis, fordermatology, such as hair transplants, for dental surgery, forophthalmic cataract surgery, for urology, for correction of urinaryfistulas and such others. With such broad application of the presentinvention possible, one is selected for illustrative continuity purposesthroughout this document. The selected application is sealing of avascular wound resulting from percutaneous entry as is frequently donein the performance of angiography, angioplasty, and atherectomyprocedures.

Percutaneous vascular access is typically done in the context ofperforming some minimally invasive surgical procedure. Minimallyinvasive techniques are used to reduce trauma to the patient. Reducedtrauma typically translates to improved patient comfort, less proceduralcomplications, and lower costs. The vessel accessed is typically thefemoral or radial artery. Access involves placement of an introducer'sdistal tip beneath the patient's skin and through the arterial wall. Tothe extent possible, percutaneous access preserves the integrity oftissue covering the artery. As a result, when the introducer is to beremoved the arterial access site is not exposed and the arterial woundis preferably closed without cutting down through the overlaying tissueto expose the site.

To accomplish hemostasis at the wound, numerous methods ofpost-introducer arterial closure have been invented. Most of these aresimilar to each other in many respects with some novel differentiatingcharacteristic separating them. All of them rely upon the clottingcascades being initiated at the wound site. All prior art devices may bebroadly classified into two groups—those that passively support onset ofthe clotting cascades at the wound site and those that actively causethe clotting cascades at the wound site. By example, mechanical methodsof holding the wound closed by clamping or suturing to preventhemorrhaging are passive methods because they merely prevent continualflushing of the site as the clot attempts to take hold. To a lesserdegree the body also does this naturally by vascular constriction. Thesecond grouping—active clotting at the wound site—includes those methodswhich place a clot inducing material at the wound site. Such clotinducing formulations are many and typically either supply thrombindirectly or stimulate thrombin release at the wound site.

Disadvantages of the prior art vary based on the method employed.Generally speaking, passive devices like clamping or suturing are eithercomplex or expensive. Clamping, for example, can be labor intensive toadminister manually and is uncomfortable for the patient by any means.Suturing, on the other hand, is complex and expensive because the woundsite is typically small, remote, and blind to the physician placing thesuture. Active devices are often costly and potentially dangerous.Active devices typically require placement of a clot-inducing foreignmaterial in the patient which necessitates either expensive pretestingfor potential allergic reactions or accepting the occasional adversereaction which could lead to anaphylactic shock and even death asreported in J. Trauma, 31:408 (1991). Transmission of infectiousdiseases can occur when the material used was manufactured from pooledhuman blood as reported in Opth. Surg., 23:640 (1992). Autologouspreparations like fibrin glue as described in U.S. Pat. No. 5,674,394 toWhitmore are well known, but significant preparation with the associatedlabor and material costs are required, and typically an additionalthrombin material must still be added at the wound site.

Despite the need for a device and method which overcomes the limitationsof the prior art, none insofar as is known has been proposed ordeveloped until the present invention.

Accordingly, it will be appreciated that there is a need for anefficient way of closing wounds. The present inventions provideadvantages over the prior devices and the prior methods used to closewounds, and also offers other advantages over the prior art and solvesother problems associated therewith.

SUMMARY OF THE INVENTION

This present invention provides methods of closing a wound including thesteps of treating a blood fluid such that the clotting cascade isinitiated and transporting the treated blood fluid to the wound to forma clot at the wound, thereby preventing fluid from passing through thewound. The invention further provides the clotting cascade initiationapparatus including a clotting cascade initiation apparatus within whicha blood fluid can be received, the blood fluid being useful fortreatment of a wound within a patient, said apparatus including asubstantially enclosed sterile containment chamber within which theblood fluid can be received and retained, and a procoagulating agentwithin the substantially enclosed sterile containment chamber wherein aclotting cascade can be initiated when the blood fluid is accepted in tothe sterile containment chamber and exposed to the wound within thepatient subsequent to the initiation of the clotting cascade such thatthe clotting cascade can be completed and a clot can form within thewound. The invention further provides the method of using the clottingcascade initiation apparatus including the steps of providing a means tosubstantially neutralize an anticoagulant. The invention furtherprovides the method of using the clotting cascade initiation apparatusincluding the steps of providing a means to substantially neutralize ananticlot. The invention further provides the method of using theclotting cascade initiation apparatus including providing a kit toconveniently practice the method.

It is believed that the present invention offers significant advantagesover the prior art methods and apparatuses. By activating the bloodfluid clotting cascade within a substantially enclosed sterile containeroutside the patient prior to placement at the wound site, a myriad ofclot performance enhancing possibilities are allowed which wouldotherwise be difficult or barred from practice if they had to beperformed in the patient's body at the wound site. With such an expandedcapability to manipulate the blood fluid, it is believed dramaticimprovements may be realized in clot formation control, efficacy,reliability, safety, cost performance; anticoagulant inhibition control,efficacy, reliability, safety, cost performance; anticlot inhibitioncontrol, efficacy, reliability, safety, cost performance; and generalapparatus ergonomic user friendliness, efficacy, reliability, safety,cost performance, and the like, should be attainable.

These and various other advantages and features of novelty thatcharacterize the present invention are pointed out with particularity inthe claims annexed hereto informing a part hereof. However, for a betterunderstanding of the present invention, its advantages and other objectsobtained by its use, reference should be made to the drawings, whichform a further part hereof and to the accompanying descriptive matter,in which there is illustrated and described preferred embodiments of thepresent invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be further described in connection with theaccompanying drawings, in which:

FIG. 1 is a mosaic pictorial of example apparatus components;

FIG. 2 is a pictorial view of the two principal apparatus componentassemblies used for illustration;

FIG. 3 is a pictorial of the assembled apparatus example as it ispositioned initially in a patient; and

FIG. 4 is a pictorial of a method and apparatus example as positionedfor return of blood fluid.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As used herein, the following terms have the following meanings: “Bloodfluid” means a fluid containing natural components of whole blood,whether derived from whole blood, whole blood extracts, or products ofex vivo cell cultures, the blood fluid containing sufficient bloodcomponents to enable a portion of the blood fluid to clot subsequent tothe initiation of a clotting cascade; “Clotting cascade(s)” means thosechemical reactions occurring in blood which result in clot formation;“Clot” means a solidified mass of blood fluid having at least 90% of theavailable fibrin polymer cross-linked; “Biocompatible” means an agent isregarded by the regulating government body to be acceptable for implantin the human body; “Procoagulant” means a component capable of causingthe blood fluid to form clot; “Anticoagulant” means a component capableof preventing blood fluid clot formation; “Homogenous clot activation”means the blood fluid volume begins to form clot at substantially thesame time and rate throughout its volume; and “Anticlot” means any ofthe naturally occurring blood fluid components which play a role indissolution of a fibrin clot. All patents, patent applications, andreferences cited herewithin are hereby incorporated by reference.

The current invention concerns a novel method and apparatus for use inhemostatic closure of tissue wounds. The invention activates theclotting cascade of the blood fluid then transports the treated bloodfluid to the wound in the patient such that the blood fluid can comeinto contact with the patient proximate the wound such that a clot isformed in the wound which prevents fluid from passing through the wound.The invention provides the opportunity to manipulate the blood fluid inrespects needed to achieve the desired clot formation in the wound. Thistypically includes the elements of basic clot formation, including butnot limited to, converting fibrinogen to a fibrin monomer then fibrinpolymer which ultimately becomes a cross-linked fibrin polymer; controlof anticoagulants including, but not limited to heparin, coumadin,aspirin, Integrilin, Reapro, or a streptokinase enzyme; and ultimatelycontrol of dissolution of the fibrin clot involving, but not limited to,serine proteases. By containing blood fluid to be used in wound clotformation and activating the clotting cascade under controlled sterileconditions outside the patient, the present invention method andapparatus provides the opportunity to manipulate the blood fluid used toform a wound clot in many ways not before possible.

An apparatus to be used for sterile enclosed containment of the bloodfluid may exist in many forms. A representative example of suchenclosures would include syringes, cartridges, vials, test tubes, jars,bags, balloons, pouches, trays, dishes, bowls, tubing, catheters,cannula in general, and the like. A common feature to such containerswould include the ability to keep the container substantially enclosedthereby preventing a level of contamination or loss of sterilityunacceptable to the user. In practice, one or more containers may beused separately or in combination. For example, a syringe connected to acatheter may be regarded as two containers or a single container with atransfer means, depending on the context of the discussion it is usedin. Both contexts are acceptable and not intended to be limiting.Likewise, a single container may have one or more chambers internal toit. As a result, a single container with multiple chambers may bereferred to as a single container or multiple containers. Again, bothreferrals are acceptable and should be interpreted in the context of thediscussion and not be interpreted as to be limiting.

Generally, the containers have at least one fluid communication elementassociated with it which connects the inside to the outside of thecontainer. A fluid communication element may have a normally open holesuch as a luer fitting, a normally closed hole such as a septum, or aselective opening such as a molecular sieve or semipermeable membrane,and the like.

Procoagulant refers to any element causing the blood fluid to form clot.Procoagulants may be any such acting material, combination of materials,or mechanical activity. Mechanical procoagulants include blood fluidagitation, thermal induction, lysis, and the like. Procoagulantmaterials include those of biological origin such as cotton, thrombin,and the like. Procoagulant further includes inorganic materials likeglass and the like. Procoagulant additionally includes synthetic organicmaterials like aminocaproic acid and the like, or polymers like dacron,nylon, polypropylene, silicone, and the like. Procoagulants may be usedsingularly or in combination.

Procoagulants, as with anticoagulant inhibitors and anticlot inhibitorsdiscussed further on, may exist as an integral function of some othercomponent, a coating on some other component, or be contained in someother component. Using procoagulants for illustrative purposes, anintegral function example would be a glass walled container and thelike. Glass causes the blood fluid to start clot formation while it alsoserves the functions of maintaining containment and sterility of theblood fluid. A coating example would be a static mixer having a surfacebonded with diatomaceous earth and the like. An example of procoagulantcontainment in some other component may be either the presence of cottonloose within a container, the holding of thrombin in at least onechamber of multiple chambers in a container, or a container withinanother container, such as an inner sealed breakable vial containingaminocaproic acid, an inner container made from porous microbeadsinfused with aminocaproic acid, and the like.

Procoagulants, anticoagulant inhibitors, anticlot inhibitors and thelike, may be added at the time of use, either before, during, or afterand either singularly, sequentially, or in any combination with eachother or with the blood fluid. Depending on the phase state of thematerial—gaseous, liquid, or solid, those skilled in the art can combineknown hardware elements to implement the transfer.

As a preferred embodiment, the combining of procoagulant, anticoagulantinhibitor, anticlot inhibitor, and the like, either before, during, orafter and either singularly, sequentially, or in any combination withblood fluid, preferably should be accomplished for homogenous respectivefunctional results throughout the blood fluid. By example, a glasswalled container can combine the functions of procoagulant, containment,and maintenance of sterility, however, unless the container is small,such as with a bundle of capillary-like tubes within a larger container,homogenous activation of the clotting cascade within the blood fluiddoes not occur. Specifically, a glass wall enclosing an undesirablelarge space would rapidly activate the clotting cascade of only thatblood fluid close to the glass wall. Blood fluid at a distance from thewall reacts slower or not at all. The less than desirable result is thatblood fluid at the glass wall forms a boundary layer of mature clot—thathaving substantial cross-linked fibrin polymer—which typically haslittle use because its adhesive capability and structure are oftendisrupted and destroyed during transport to the wound site.

Likewise, the other zones of the blood fluid without clotting cascadeactivation do not clot in the wound site as desired. This clottingmechanism may be used but the aforementioned inferior results are to beexpected. Hence it is a preferred embodiment to provide ways to improvehomogeneity of the desired blood fluid reaction. Apparatus examplesaccomplishing this include a static mixer, dynamic mixer, a porousmatrix, and the like. Examples of a porous matrix include glass beads orcotton in a container—both provide a high surface area for intimatecontact and turbulence within the blood fluid as it passes though thematrix. Thus, it may otherwise be stated that flowing blood fluid ispreferred over pooled static blood and turbulent flow is preferred overlaminar flow.

With regard to procoagulant, anticoagulant inhibitor, anticlot inhibitorand like materials, they may constitute more than one function, such asalso making a static mixer, and the like, or they be separate asdiscussed above. This brings forth other embodiments and advantages ofthe invention. Specifically, it is also possible to classifyprocoagulant, anticoagulant inhibitor, anticlot inhibitor, and the likeagents collectively as either catalytic or non-catalytic materials. Byexample, cotton is a catalytic material in the context that blood fluidis combined with it to initiate a reaction (procoagulation) in the bloodfluid. It is then separated, trace cotton fiber notwithstanding, andsubstantially retained from the blood fluid prior to returning the bloodfluid to the wound site. To the contrary, the liquid drug protaminesulfate may be added to the blood fluid as a non-catalytic material, forexample via an injection port septum on the enclosed sterile container,to initiate a reaction (inhibit the anticoagulant heparin) and stay withthe blood fluid when it is returned to the wound site. By furtherexample, diethylaminoethyl cellulose (DEAE), a catalytic material, maybe held inside of a container via filtration methods and the like. Whenheparin anticoagulated blood fluid is added to the container, DEAEcellulose binds with the heparin removing it from the blood fluid thuskeeping both the heparin and itself from returning to the wound site,trace presence remaining in blood fluid notwithstanding. In the interestof avoiding adverse patient outcomes, like an allergic response, it is apreferred embodiment of the present invention to not leave significantforeign materials in the blood fluid that is being returned to the woundsite. As such, a benefit of the present invention is that bymanipulating blood fluid to initiate the clotting cascade outside thepatient, it is possible to use many more agents in catalytic form forprocoagulation, anticoagulation inhibition, anticlot inhibition, and thelike, than would be allowed if the selection was limited to agents thathad to be biocompatible, e.g., approved for implant in the body. Thisincreased selection allows for reduction or elimination of compromisesin product efficacy, reliability, and safety. Further, even when workingwith non-catalytic implantable agents, the invention has new benefitssuch as the ability to ensure appropriate blood fluid mixing,concentration, clot volume and the like when performed outside the body.

Anticoagulant inhibitor is used to prevent any clot inhibiting agentspresent in the blood fluid from performing their function. Ananticoagulant inhibitor may be specific or general in function. Byexample, thrombin acts as a procoagulant but can serve double duty as ananticoagulant inhibitor simply by being present in volumes large enoughto overwhelm the volume of anticoagulant present in the blood fluid.With the exception of protein deficiencies associated with hemophilia,anticoagulation typically occurs as the result of adding a foreign agentto the blood. Such agents typically include heparin, coumadin, aspirin,Integrilin, Reapro, or a streptokinase enzyme. In catalytic form,polymers of selective electrical charge, diethylaminoethyl cellulose,and the like, may be placed in the blood fluid, singularly or incombination with an anticoagulant inhibiting drug and the like, toattract and hold an anticoagulant. In the non-catalytic form, protaminesulfate and the like may be used to render inactive a drug like heparin.Examples and the preferred manner and form of introduction have beendiscussed above.

Anticlot inhibitor is a term used to describe anything that impairs thefunction of fibrin clot degradation. Degradation of fibrin clots isnaturally a function of plasmin, a serine protease that circulates asthe inactive proenzyme, plasminogen. Anticlot inhibitors thus may servein one way to disrupt the function of plasmin, plasminogen, and thelike. Anticlot inhibitors may have value in extending the life of awound sealing clot if desired. Examples of such inhibitors would betranexamic acid, plasminogen binding material (PBM) available fromBioforma Research & Consulting, Inc., and the like. They may be appliedin substantially the same way as discussed for anticoagulant inhibitorsand procoagulants. Examples of the preferred manner and form ofintroduction have been discussed above.

The preferred embodiments of the apparatus of the present invention maybe highly varied and is typically dependent on the individualapplication considering clinical situation, physician preference, andthe like. As such, a clinical situation is selected and physicianpreference stated here for purposes of providing an illustrative exampleof one form of the invention apparatus. Presentation of this scenario isintended to be an instructive example of how the invention may beadapted to individual needs and should not be interpreted in a limitedcontext as to how the invention applies. When used as a reference, thoseskilled in the art will be able to alter configurations and attributesof the apparatus to the same and other needs without departing from thescope and spirit of the present invention. The present example selectedis that of post-introducer arterial wound closure following anangiographic procedure and the like. Post-introducer arterial woundclosure typically involves the closure of a wound within an arterialwall such as the femoral artery, radial artery, and the like. Suchwounds are typically subcutaneous in the sense that the artery iscovered by tissue rather than being exposed by cut down through thetissue until the artery is visible to the practitioner. In the presentillustration, an apparatus in configured for use typically withautologous whole blood.

FIG. 1 shows a typical array of components required to practice theinvention when used to hemostatically close a post-introducer arterialwound. An advantage of the present invention apparatus example is thatthe components used are with rare exception standard off-the-shelfcomponents commonly used throughout the medical industry andrecognizable to those skilled in the art. A polymer 12 cc syringe 1consisting of a plunger rod 2 connected to a fluid sealing piston 4 isslidingly placed within a cylinder 3 thereby allowing the cylinder toreceive and expel fluids and the like through the distal port 5 of thesyringe 1. A three-way connector 6 permits fluid communication betweenits three ports. A three-way valve connector 7 permits selective fluidcommunication between its three ports. Luer lock cylinder cap fittings 8and 10, typically made of polycarbonate, are used to form a containerwhen assembled to the ends of cylinder 9, also typically made ofpolycarbonate. Tubing section 11 represents a short section ofsubstantially clear tubing typically made from the polymer polypropyleneand the like. A porous material 12 typically made from cotton, open cellpolyurethane, and the like will be used as a component in thefabrication of a bacteria resistant air vent. The porous materials of 13and 15 represent both filtration and procoagulant materials and aretypically both made of cotton and the like and typically resemble acotton-ball consistency. Item 14 represents the anticoagulant bindingmaterial diethylaminoethyl (DEAE) cellulose. Item 16 represents theconstruct of a simple pulsatile indicator consisting of a substantiallyclear tube typically made of a polymer and having one end open 17 andthe opposing end 18 closed either by addition of a plug or a melting andthe like of the tube material. Tube 19 represents a length of tubingmade of polyethylene and the like which will be used as a catheter. Theouter diameter of tube 19 is typically the same French size as thatspecified for the introducer with which it is intended to be used. Thedistal end 20 is closed to fluid flow and forms an atraumatic tip forplacement in an artery. The port 21 is proximal to the distal end 20 bytypically 4 cm and typically approximates two-thirds the inner diameterof the tube and is placed through one wall of the tube 19 therebypermitting fluid communication between the outside of the tube with theinside of the tube extending fully to the proximal end 20 of tube 19.Item 23 represents a mating connector for assembly to and use with theproximal end 20 of tube 19 and at least one open port of the three-wayconnector 6. Item 24 represents a snap collar intended to be slidinglyplaced over tube 19 and bonded to the outside of tube 19 along itslength between port 21 and proximal end 22. The contour of the snap fitof collar 24 is configured to connect with any one of several differentbrands of manufacture of introducer, an example of which is illustratedin FIG. 3.

FIG. 2 represents a typical assembly of the subcomponents in FIG. 1 intoa blood fluid processor 25 and a blood fluid transfer catheter 29. Theassembly 25 represents the three-way connector 6 attached to open end ofthe pulsatile indicator 16 and distal end of the assembly of eithercylinder cap fittings 8 or 10 from FIG. 1 as fitted to the cylinder 9 ofFIG. 1 therein containing distally the cotton material 13, medially thediethylaminoethyl cellulose material 14, and proximally the cottonmaterial 15. The function of the cotton material 13 is primarily that ofa filter which is used to retain the loose fibrous diethylaminoethyl(DEAE) cellulose material 14. The DEAE cellulose material serves to bindwith and retain the anticoagulant, heparin, in the blood fluid to beused. The function of the cotton material 15 is to serve as a filter toretain the DEAE cellulose and also as a procoagulant of the blood fluid.Item 30 represents the construct of a bacteria resistant air vent. Item12 from FIG. 1 placed in the distal end of tube 11 from FIG. 1. Theproximal end of item 30 is attached to one port of the three-way valve 7of FIG. 1 which in turn mates the syringe port 5 of FIG. 1 with theproximal end cap connector 8 of FIG. 1 which is part of theaforementioned assembly containing the cotton and DEAE. The item of 29represents the completed catheter assembly discussed above.

FIG. 3 represents the completed apparatus assembly in-place within theintroducer and patient as it would typically be used. Catheter 29 isshown placed through the introducer 32 with proximal end 33 snap fittedto the catheter and extending beyond the distal end 34 until port 21 isin fluid communication with the inside of artery 36 which issubstantially enclosed within living tissue 35. Accordingly, blood fluidflows through port 21 up through catheter 29 and into the pulsatileindicator 16 and the containing apparatus assembly 31. The arterialsystolic/diastolic pressure variation causes blood fluid within thepulsatile indicator 16 to vary compression of the entrapped air spacewithin 16 thus providing positive indication of the presence of port 21within the artery. The three-way valve of 31 is turned to permitwithdrawal of the syringe plunger thereby encouraging blood fluid toflow through the cotton and DEAE cellulose. As this occurs trapped airwithin the syringe may be exhausted by switching the three-way valve tothe exhaust side and advancing the plunger. Once substantially exhaustedof air, the three-way valve is returned to the position which permitsblood fluid to enter the syringe upon withdrawal of the plunger. Asblood fluid flows through the apparatus toward the accumulating syringe,DEAE binds with and removes heparin from the blood fluid and the cottonpresent causes activation of the clotting cascade within the blood fluidas it passes through the cotton on its way to the accumulating syringe.

FIG. 4 represents the placement of blood fluid having an activatedclotting cascade at the wound site. Both the catheter and introducer arewithdrawn from the patient until there is a cessation of movement withinthe blood fluid 39 within the pulsatile indicator thus indicating thatthe catheter's distal port is now outside the artery. Once this has beenestablished, the syringe plunger is advanced thereby drivingclot-activated blood fluid 40 out the distal catheter port anddepositing it about the wound where clotting continues. As the bloodfluid 40 continues to advance to a mature clot, proximal pressure isapplied to the artery and both the introducer and catheter are fullyremoved from the patient. After typically 3 to 5 minutes, proximaldirect pressure may be eliminated and the procedure considered complete.Although not presented in this example, anticlot inhibition may havealso been used if desired as previously discussed. Those skilled in theart will observe that blood fluid between the distal catheter port andthe DEAE cellulose material escaped removal of anticoagulant.Experimentation has shown that such residual anticoagulant does notinhibit clot formation in the considerable larger volume of activatedblood fluid. However, if this were a problem, it certainly would bepossible to have a closed loop apparatus so that blood fluid does nottravel the same fluid communication conduit to and from the wound area.Alternatively, an anticoagulant inhibitor may be placed within thecatheter starting at the distal port and extend all the way back throughto the proximal end of the device if desired. These alternatives merelyillustrate examples of the tremendous latitude available to a productdesigner within the present invention.

In providing the user with a functional construct of the presentinvention, it may be desirable to provide the user with a kit ofcomponents bundled together for ease of use. As with other aspects ofthe invention illustrated earlier, this invention aspect can take manyforms and is typically dependent on clinical application, userpreferences, and the like. As such, the following is merely anillustrative example of what a kit may consist of and should not beinterpreted as a limitation of the present invention. For the sake ofcontinuity with previous illustrations, this illustration will be in thecontext of a typical kit for use with minimally invasive angiographicprocedures and the like. Thus, the kit may contain a wound closureapparatus of the present invention singularly or in combination with oneor more of the following: an introducer, guidewire, dilator, obturator,collapsible catheter sheath, Seldinger needle, balloon catheter,infusion catheter, stent, scalpel, suture line, needle, pouch, tray,tray lid, instructions for use, adhesive identification label, sterilityindicator, and the like.

It is to be understood, however, that even though numerouscharacteristics and advantages of the present invention have been setforth in the foregoing description, together with details of thestructure and function of present invention, the sequence or order ofthe specific steps, or the actual compositions or materials used mayvary somewhat. Furthermore, it will be appreciated that this disclosureis illustrative only and that changes may be made in detail, especiallyin matters of shape, size, arrangement of parts or sequence or elementsof aspects of the invention within the principles of the invention tothe full extent indicated by the broad general meaning of the terms inwhich the appended claims, which form a further part hereof, areexpressed.

What is claimed is:
 1. A method for using a volume of a patient's wholeblood to close a subcutaneous arterial wound in the patient, the methodcomprising: introducing a catheter percutaneously into an artery of thepatient; locating an external wall of an artery comprising thesubcutaneous arterial wound; providing a porous matrix; homogenouslyexposing the patient's whole blood to the porous matrix to initiate aclotting cascade in the whole blood; situating the patient's whole bloodat a position proximate the wound as the patient's whole blood isclotting; removing the catheter from the artery as the patient's wholeblood is clotting; and holding a subcutaneous mass comprising thepatient's whole blood in position proximate the arterial wound as thepatient's whole blood continues to clot; whereby a hemostatic closurecomprising the patient's whole blood is formed.
 2. The method of claim1, wherein the hemostatic closure comprises cross-linked polymer.
 3. Themethod of claim 1, wherein the introducing is performed prior to thehomogenously exposing.
 4. The method of claim 1, wherein the locating isperformed prior to the homogenously exposing.
 5. The method of claim 1,wherein the providing is performed prior to the homogenously exposing.6. The method of claim 1, wherein the hemostatic closure is establishedabout a surface of the artery comprising the arterial wound.
 7. Themethod of claim 1, wherein the porous matrix is not of biologicalorigin.
 8. The method of claim 1, further comprising transporting thepatient's whole blood from a position outside the patient's body to theposition proximate the arterial wound.
 9. The method of claim 1, whereinthe hemostatic closure is biodegradable.
 10. The method of claim 1,wherein the patient's whole blood comprises an anticoagulant.
 11. Themethod of claim 1, wherein the hemostatic closure comprises a gel-likemass.
 12. The method of claim 11, wherein the gel-like mass comprisesfibrin polymer and at least 90% of the available fibrin polymer iscross-linked.
 13. The method of claim 12, wherein the step of holdingthe subcutaneous mass comprises holding the patient's whole blood inposition outside the artery as the patient's whole blood continues toclot.
 14. The method of claim 13, wherein the hemostatic closurecomprising the patient's whole blood is formed by holding thesubcutaneous mass comprising the patient's whole blood adjacent to andoutside the arterial wound.
 15. The method of claim 11, wherein the stepof holding the subcutaneous mass comprises holding the patient's wholeblood in position outside the artery as the patient's whole bloodcontinues to clot.
 16. The method of claim 15, wherein the hemostaticclosure comprising the patient's whole blood is formed by holding thesubcutaneous mass comprising the patient's whole blood adjacent to andoutside the arterial wound.
 17. The method of claim 1, wherein the stepof holding the subcutaneous mass comprises holding the patient's wholeblood in position outside the artery as the patient's whole bloodcontinues to clot.
 18. The method of claim 17, wherein the hemostaticclosure comprising the patient's whole blood is formed by holding thesubcutaneous mass comprising the patient's whole blood adjacent to andoutside the arterial wound.